Cochlear, the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) cleared the Cochlear Baha 5 SuperPower Sound Processor for use in the United States.
Designed for children and adults with higher degrees of mixed hearing loss, the Baha 5 SuperPower is engineered to make difficult listening situations easier and more enjoyable.
It is not only the strongest member of the Baha portfolio, it is the first and only super power bone conduction solution with smart, direct-to-device wireless technology for patients with significant hearing loss.
Building off of the award-winning Baha 5 Sound Processor, the Baha 5 SuperPower is designed to provide an unparalleled hearing experience. Features like Bluetooth® Smart and Made for iPhone® allow users to stream audio directly from iPhone®, iPad® and iPod touch®.
With access to Cochlear™ True Wireless™ technology, users will also benefit from a range of accessories that are designed to further improve hearing performance and overall hearing experience.
The Baha 5 SuperPower is the first and only behind-the-ear sound processor with a fitting range up to 65 dB SNHL. Patients with this type and degree of hearing loss often struggle more than most to hear and understand speech, especially in noisy situations.
Many of these patients currently use a body-worn solution to help improve their hearing experience, but still have difficulty due to insufficient features and outdated audio processing technology.
"The FDA clearance of the Baha 5 SuperPower Sound Processor is a very important milestone for the industry and patients," said Tony Manna, President of Cochlear Americas. "It means that the people who need it most can now benefit from a device that not only provides the amplification they need, but the ability to connect wirelessly to their favorite electronic devices, including smartphones and TVs."
The Baha 5 SuperPower combines two proven Cochlear technologies in one device, harnessing Baha bone conduction technology with that of the widely-used Nucleus® System (a cochlear implant system).
The surgery is based on the same well-proven implant technology used in more than 125,000 patients over the last 35 years. It is a flexible option that can be used on both an abutment system (Baha Connect System) and a magnetic system (Baha Attract System).
To date, more than 50 people have been fit with the device in Europe and the United States.
"Patient response has been extremely positive," said Mats Dotevall, Director of Design & Development, Cochlear Bone Anchored Solutions AB. "Early results from European clinics show great satisfaction in terms of loudness, speech understanding and sound quality."
Commercial availability in the United States is estimated for summer 2016.